Allergan's Botox gets EU thumbs-up for incontinence

Allergan has been boosted by the news that Botox, best known as a wrinkle smoother, has received an positive agreement for approval in 14 European Union countries for treating certain patients with urinary incontinence.

The recommendation from the Irish Medicines Board is for Botox (botulinum toxin type A) to be approved for the management of urinary incontinence in adults with neurogenic detrusor overactivity resulting from neurogenic bladder due to spinal cord injury (SCI) or multiple sclerosis. Ireland served as the reference member state in the European Union's mutual recognition procedure - the other countries involved are Austria, Belgium, Denmark, Finland, Germany, Greece, Iceland, Italy, Luxemburg, Norway, Portugal, Spain and Sweden.

The backing is based on two Phase III trials involving nearly 700 patients with either SCI or MS who were not adequately managed with at least one anticholinergic therapy, such as Pfizer’s Detrol (tolterodine), Johnson & Johnson’s Ditropan (oxybutynin) and Astellas/GlaxoSmithKline's Vesicare (solifenacin).

Targeted injections of Botox into the bladder muscle were shown to reduce involuntary contractions and increase bladder capacity. Treatment was shown to be effective within two weeks and lasted for approximately eight-ten months, Allergan says, and the data showed there was a significant reduction in frequency of leakage reported in Botox-treated patients compared to placebo.

The US group noted that 60%-80% of people with MS and 75%-80% with SCI have some degree of bladder dysfunction, adding that in Europe, there are around 650,000 people living with the former; on average 11,000 people are diagnosed with SCI each year.

Douglas Ingram, president of Allergan in Europe, Africa and the Middle East, said that for these patients, "gaining effective control over their bladder and staying dry can be a significant step towards improving daily functioning and overall quality of life". He added that "our task now is to work closely with the national health authorities to secure the relevant national licences".

Botox is Allergan's biggest-earner and second-quarter sales rose to $418.4 million, up 16%. Most of that comes from reducing wrinkles, but it also has approvals for a number of other indications, including chronic migraine, certain facial spasms (such as uncontrolled blinking and involuntary twitching) cervical dystonia, excessive sweating of the armpits and the treatment of post-stroke spasticity in the hand and wrist.